ClinicalTrials.gg
Status unknownNCT04073719APULUpdated Aug 30, 2019

Apple Cider Vinegar for the Prevention of Urinary Lithiasis (APUL)

An interventional study of Apple Cider Vinegar and Other Beverage in Kidney Stones, Urolithiasis, Hypocitraturia, sponsored by United States Naval Medical Center, San Diego. Status unknown. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-30.

Sponsored by United States Naval Medical Center, San Diego · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to assess whether certain beverages can increase urinary citrate levels in healthy individuals with no history of kidney disease.

Read the detailed description

Higher urinary citrate levels have been shown to decrease one's risk of developing kidney stones. The study will compare apple cider vinegar, coconut water, diet citric soda and lemonade and determine which is superior at raising citrate levels. Research participants will consume two of the four drinks, each for 7 day periods, according to a prescribed regimen. Throughout the course of the study, participants will periodically provide blood draws for metabolic panels, as well as 24-hour urine samples to measure citrate levels. There will be 12 study arms, accounting for the permutations of two drinks for each patients out of four possibilities. 3 participants per arm is the goal, for a total of 36, but the recruitment aim is 50 participants, to account for dropout and noncompliance.

02

Conditions studied

  • Kidney Stones, Urolithiasis, Hypocitraturia

Keywords

  • Kidney Stones, Urolithiasis, Hypocitraturia, Apple Cider Vinegar
03

In context

Kidney Calculi

509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.

This study's planned enrollment of 50 is below the median of 86 across 391 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

United States Naval Medical Center, San Diego is the lead sponsor of 65 studies on the registry; 6 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female volunteers 18-65 years old

Exclusion criteria

Exclusion Criteria:

  • History of peptic ulcer disease or gastroparesis
  • Pregnant females
  • History of chronic kidney disease
  • History of urolithiasis
  • Currently taking medications that interfere with urinary electrolyte excretion (thiazide and loop diuretics)javascript:document.
  • History of Diabetes
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Apple Cider Vinegar + Coconut Water

    Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days.

    Dietary Supplement: Apple Cider Vinegar

  • Experimental
    Apple Cider Vinegar + Citric Soda

    Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days.

    Dietary Supplement: Apple Cider Vinegar

  • Experimental
    Apple Cider Vinegar + Lemonade

    Patients will drink apple cider vinegar for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.

    Dietary Supplement: Apple Cider Vinegar

  • Experimental
    Coconut Water + Apple Cider Vinegar

    Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days.

    Dietary Supplement: Apple Cider Vinegar

  • Experimental
    Coconut Water + Citric Soda

    Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days.

    Dietary Supplement: Other Beverage

  • Experimental
    Coconut Water + Lemonade

    Patients will drink coconut water for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.

    Dietary Supplement: Other Beverage

  • Experimental
    Citric Soda + Apple Cider Vinegar

    Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days.

    Dietary Supplement: Apple Cider Vinegar · Dietary Supplement: Other Beverage

  • Experimental
    Citric Soda + Coconut Water

    Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days.

    Dietary Supplement: Other Beverage

  • Experimental
    Citric Soda + Lemonade

    Patients will drink citric soda for 7 days. After a washout period of 2 weeks, patients will then drink lemonade for 7 days.

    Dietary Supplement: Other Beverage

  • Experimental
    Lemonade + Apple Cider Vinegar

    Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink apple cider vinegar for 7 days.

    Dietary Supplement: Apple Cider Vinegar

  • Experimental
    Lemonade + Coconut Water

    Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink coconut water for 7 days.

    Dietary Supplement: Other Beverage

  • Experimental
    Lemonade + Citric Soda

    Patients will drink lemonade for 7 days. After a washout period of 2 weeks, patients will then drink citric soda for 7 days.

    Dietary Supplement: Other Beverage

Interventions

  • Dietary supplementApple Cider Vinegar

    Will drinking apple cider vinegar increase urinary citrate levels to a greater degree than other beverages and which beverages produce the most significant effects compared against one another.

  • Dietary supplementOther Beverage

    To what degree do other high citrate beverages impact urinary citrate output.

06

What researchers measure

Primary outcomes

  1. Apple Cider Vinegar Urinary Citrate Increase

    Determine the change in urinary citrate levels due to the addition of apple cider vinegar to the diet

    Time frame: 1 week

Secondary outcomes

  1. Apple Cider Vinegar and urinary pH

    Determine the effect of apple cider vinegar on urinary pH

    Time frame: 1 week

  2. Apple Cider Vinegar Against Other Beverages

    Compare the effect of apple cider vinegar on urinary citrate with that of known citrate-rich beverages (lemonade, citrus based soda, coconut water)

    Time frame: 4 weeks

  3. Palatability Evaluation

    Compare the palatability of apple cider vinegar and other known citrate-rich beverages (lemonade, citrus based soda, coconut water). Patients will keep daily log whwere they can free write any side effects (from palatability perspective and otherwise). At the end of the study a 2 question survery (Likert scale format) will be filled in which participants will answer the liklihood of their willingness to consume the beverage daily for the prevention of kidney stones.

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31. PubMed 22498635 ↗
  • Pearle MS, Calhoun EA, Curhan GC; Urologic Diseases of America Project. Urologic diseases in America project: urolithiasis. J Urol. 2005 Mar;173(3):848-57. doi: 10.1097/01.ju.0000152082.14384.d7. PubMed 15711292 ↗
  • Johnson CM, Wilson DM, O'Fallon WM, Malek RS, Kurland LT. Renal stone epidemiology: a 25-year study in Rochester, Minnesota. Kidney Int. 1979 Nov;16(5):624-31. doi: 10.1038/ki.1979.173. PubMed 548606 ↗
  • Bansal AD, Hui J, Goldfarb DS. Asymptomatic nephrolithiasis detected by ultrasound. Clin J Am Soc Nephrol. 2009 Mar;4(3):680-4. doi: 10.2215/CJN.05181008. Epub 2009 Mar 4. PubMed 19261817 ↗
  • Bhatti UH, Duffy AJ, Roberts KE, Shariff AH. Nephrolithiasis after bariatric surgery: A review of pathophysiologic mechanisms and procedural risk. Int J Surg. 2016 Dec;36(Pt D):618-623. doi: 10.1016/j.ijsu.2016.11.025. Epub 2016 Nov 12. PubMed 27847289 ↗
  • Maalouf NM, Tondapu P, Guth ES, Livingston EH, Sakhaee K. Hypocitraturia and hyperoxaluria after Roux-en-Y gastric bypass surgery. J Urol. 2010 Mar;183(3):1026-30. doi: 10.1016/j.juro.2009.11.022. Epub 2010 Jan 21. PubMed 20096421 ↗
  • Sakhaee K. Nephrolithiasis as a systemic disorder. Curr Opin Nephrol Hypertens. 2008 May;17(3):304-9. doi: 10.1097/MNH.0b013e3282f8b34d. PubMed 18408483 ↗
  • Sakhaee K, Maalouf NM, Kumar R, Pasch A, Moe OW. Nephrolithiasis-associated bone disease: pathogenesis and treatment options. Kidney Int. 2011 Feb;79(4):393-403. doi: 10.1038/ki.2010.473. Epub 2010 Dec 1. PubMed 21124301 ↗
  • Sakhaee K. Recent advances in the pathophysiology of nephrolithiasis. Kidney Int. 2009 Mar;75(6):585-95. doi: 10.1038/ki.2008.626. Epub 2008 Dec 10. PubMed 19078968 ↗
  • Worcester EM, Coe FL. Clinical practice. Calcium kidney stones. N Engl J Med. 2010 Sep 2;363(10):954-63. doi: 10.1056/NEJMcp1001011. No abstract available. PubMed 20818905 ↗
  • Curhan GC, Taylor EN. 24-h uric acid excretion and the risk of kidney stones. Kidney Int. 2008 Feb;73(4):489-96. doi: 10.1038/sj.ki.5002708. Epub 2007 Dec 5. PubMed 18059457 ↗
  • Nicar MJ, Skurla C, Sakhaee K, Pak CY. Low urinary citrate excretion in nephrolithiasis. Urology. 1983 Jan;21(1):8-14. doi: 10.1016/0090-4295(83)90113-9. PubMed 6823713 ↗
  • Rudman D, Kutner MH, Redd SC 2nd, Waters WC 4th, Gerron GG, Bleier J. Hypocitraturia in calcium nephrolithiasis. J Clin Endocrinol Metab. 1982 Dec;55(6):1052-7. doi: 10.1210/jcem-55-6-1052. PubMed 7130336 ↗
  • Pak CY, Poindexter JR, Adams-Huet B, Pearle MS. Predictive value of kidney stone composition in the detection of metabolic abnormalities. Am J Med. 2003 Jul;115(1):26-32. doi: 10.1016/s0002-9343(03)00201-8. PubMed 12867231 ↗
  • Pak CY. Citrate and renal calculi: an update. Miner Electrolyte Metab. 1994;20(6):371-7. PubMed 7783699 ↗
  • Zuckerman JM, Assimos DG. Hypocitraturia: pathophysiology and medical management. Rev Urol. 2009 Summer;11(3):134-44. PubMed 19918339 ↗
  • Ryall RL. Urinary inhibitors of calcium oxalate crystallization and their potential role in stone formation. World J Urol. 1997;15(3):155-64. doi: 10.1007/BF02201852. No abstract available. PubMed 9228722 ↗
  • Sheng X, Jung T, Wesson JA, Ward MD. Adhesion at calcium oxalate crystal surfaces and the effect of urinary constituents. Proc Natl Acad Sci U S A. 2005 Jan 11;102(2):267-72. doi: 10.1073/pnas.0406835101. Epub 2004 Dec 29. PubMed 15625112 ↗
  • Kok DJ, Papapoulos SE, Bijvoet OL. Excessive crystal agglomeration with low citrate excretion in recurrent stone-formers. Lancet. 1986 May 10;1(8489):1056-8. doi: 10.1016/s0140-6736(86)91329-2. PubMed 2871335 ↗
  • Preminger GM, Sakhaee K, Skurla C, Pak CY. Prevention of recurrent calcium stone formation with potassium citrate therapy in patients with distal renal tubular acidosis. J Urol. 1985 Jul;134(1):20-3. doi: 10.1016/s0022-5347(17)46963-1. PubMed 4009822 ↗
  • Pak CY, Fuller C, Sakhaee K, Preminger GM, Britton F. Long-term treatment of calcium nephrolithiasis with potassium citrate. J Urol. 1985 Jul;134(1):11-9. doi: 10.1016/s0022-5347(17)46962-x. PubMed 3892044 ↗
  • Pak CY, Sakhaee K, Fuller C. Successful management of uric acid nephrolithiasis with potassium citrate. Kidney Int. 1986 Sep;30(3):422-8. doi: 10.1038/ki.1986.201. PubMed 3784284 ↗
  • Barcelo P, Wuhl O, Servitge E, Rousaud A, Pak CY. Randomized double-blind study of potassium citrate in idiopathic hypocitraturic calcium nephrolithiasis. J Urol. 1993 Dec;150(6):1761-4. doi: 10.1016/s0022-5347(17)35888-3. PubMed 8230497 ↗
  • Ettinger B, Pak CY, Citron JT, Thomas C, Adams-Huet B, Vangessel A. Potassium-magnesium citrate is an effective prophylaxis against recurrent calcium oxalate nephrolithiasis. J Urol. 1997 Dec;158(6):2069-73. doi: 10.1016/s0022-5347(01)68155-2. PubMed 9366314 ↗
  • Soygur T, Akbay A, Kupeli S. Effect of potassium citrate therapy on stone recurrence and residual fragments after shockwave lithotripsy in lower caliceal calcium oxalate urolithiasis: a randomized controlled trial. J Endourol. 2002 Apr;16(3):149-52. doi: 10.1089/089277902753716098. PubMed 12028622 ↗
  • Kang DE, Maloney MM, Haleblian GE, Springhart WP, Honeycutt EF, Eisenstein EL, Marguet CG, Preminger GM. Effect of medical management on recurrent stone formation following percutaneous nephrolithotomy. J Urol. 2007 May;177(5):1785-8; discussion 1788-9. doi: 10.1016/j.juro.2007.01.061. PubMed 17437820 ↗
  • Mattle D, Hess B. Preventive treatment of nephrolithiasis with alkali citrate--a critical review. Urol Res. 2005 May;33(2):73-9. doi: 10.1007/s00240-005-0464-8. Epub 2005 May 4. PubMed 15875173 ↗
  • Koff SG, Paquette EL, Cullen J, Gancarczyk KK, Tucciarone PR, Schenkman NS. Comparison between lemonade and potassium citrate and impact on urine pH and 24-hour urine parameters in patients with kidney stone formation. Urology. 2007 Jun;69(6):1013-6. doi: 10.1016/j.urology.2007.02.008. PubMed 17572176 ↗
  • Seltzer MA, Low RK, McDonald M, Shami GS, Stoller ML. Dietary manipulation with lemonade to treat hypocitraturic calcium nephrolithiasis. J Urol. 1996 Sep;156(3):907-9. PubMed 8709360 ↗
  • Kang DE, Sur RL, Haleblian GE, Fitzsimons NJ, Borawski KM, Preminger GM. Long-term lemonade based dietary manipulation in patients with hypocitraturic nephrolithiasis. J Urol. 2007 Apr;177(4):1358-62; discussion 1362; quiz 1591. doi: 10.1016/j.juro.2006.11.058. PubMed 17382731 ↗
  • Penniston KL, Steele TH, Nakada SY. Lemonade therapy increases urinary citrate and urine volumes in patients with recurrent calcium oxalate stone formation. Urology. 2007 Nov;70(5):856-60. doi: 10.1016/j.urology.2007.06.1115. Epub 2007 Oct 24. PubMed 17919696 ↗
  • Odvina CV. Comparative value of orange juice versus lemonade in reducing stone-forming risk. Clin J Am Soc Nephrol. 2006 Nov;1(6):1269-74. doi: 10.2215/CJN.00800306. Epub 2006 Aug 30. PubMed 17699358 ↗
  • Penniston KL, Nakada SY, Holmes RP, Assimos DG. Quantitative assessment of citric acid in lemon juice, lime juice, and commercially-available fruit juice products. J Endourol. 2008 Mar;22(3):567-70. doi: 10.1089/end.2007.0304. PubMed 18290732 ↗
  • Haleblian GE, Leitao VA, Pierre SA, Robinson MR, Albala DM, Ribeiro AA, Preminger GM. Assessment of citrate concentrations in citrus fruit-based juices and beverages: implications for management of hypocitraturic nephrolithiasis. J Endourol. 2008 Jun;22(6):1359-66. doi: 10.1089/end.2008.0069. PubMed 18578663 ↗
  • Patel RM, Jiang P, Asplin J, Granja I, Capretz T, Osann K, Okhunov Z, Landman J, Clayman RV. Coconut Water: An Unexpected Source of Urinary Citrate. Biomed Res Int. 2018 Nov 1;2018:3061742. doi: 10.1155/2018/3061742. eCollection 2018. PubMed 30515390 ↗
  • Yamashita H. Biological Function of Acetic Acid-Improvement in Obesity and Glucose Tolerance by Acetic Acid in Type 2 Diabetic Rats. Crit Rev Food Sci Nutr. 2016 Jul 29;56 Suppl 1:S171-5. doi: 10.1080/10408398.2015.1045966. PubMed 26176799 ↗
  • Yamashita H, Fujisawa K, Ito E, Idei S, Kawaguchi N, Kimoto M, Hiemori M, Tsuji H. Improvement of obesity and glucose tolerance by acetate in Type 2 diabetic Otsuka Long-Evans Tokushima Fatty (OLETF) rats. Biosci Biotechnol Biochem. 2007 May;71(5):1236-43. doi: 10.1271/bbb.60668. Epub 2007 May 7. PubMed 17485860 ↗
  • Kondo T, Kishi M, Fushimi T, Ugajin S, Kaga T. Vinegar intake reduces body weight, body fat mass, and serum triglyceride levels in obese Japanese subjects. Biosci Biotechnol Biochem. 2009 Aug;73(8):1837-43. doi: 10.1271/bbb.90231. Epub 2009 Aug 7. PubMed 19661687 ↗
  • Brighenti F, Castellani G, Benini L, Casiraghi MC, Leopardi E, Crovetti R, Testolin G. Effect of neutralized and native vinegar on blood glucose and acetate responses to a mixed meal in healthy subjects. Eur J Clin Nutr. 1995 Apr;49(4):242-7. PubMed 7796781 ↗
  • White AM, Johnston CS. Vinegar ingestion at bedtime moderates waking glucose concentrations in adults with well-controlled type 2 diabetes. Diabetes Care. 2007 Nov;30(11):2814-5. doi: 10.2337/dc07-1062. Epub 2007 Aug 21. No abstract available. PubMed 17712024 ↗
  • Johnston CS, Kim CM, Buller AJ. Vinegar improves insulin sensitivity to a high-carbohydrate meal in subjects with insulin resistance or type 2 diabetes. Diabetes Care. 2004 Jan;27(1):281-2. doi: 10.2337/diacare.27.1.281. No abstract available. PubMed 14694010 ↗
  • Shishehbor F, Mansoori A, Sarkaki AR, Jalali MT, Latifi SM. Apple cider vinegar attenuates lipid profile in normal and diabetic rats. Pak J Biol Sci. 2008 Dec 1;11(23):2634-8. doi: 10.3923/pjbs.2008.2634.2638. PubMed 19630216 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04073719
Lead sponsor
United States Naval Medical Center, San Diego
Responsible party
Christine Herforth (Urology Resident, United States Naval Medical Center, San Diego) — Principal investigator
First posted
Aug 29, 2019
Start date
Sep 1, 2019 (estimated)
Primary completion
May 31, 2021 (estimated)
Completion
May 31, 2022 (estimated)
Last update
Aug 30, 2019

Study contacts

Christine M Herfroth, MD
Contact
christine.m.herforth.mil@mail.mil
6195327227
Jesse E Resovsky, BS
Contact
jreso001@gmail.com
6195327226

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Apple cider vinegar

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